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N/A N=60 Randomized Double-blind Treatment

Propofol EC50 for Inducing Loss of Consciousness in General Combined Epidural Anesthesia

Gastric Cancer

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Propofol EC50 for Inducing Loss of Conciousness — 2.97; 3.36 ug/ml

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
5-8ml 0.375% ropivacaine (Drug); 5-8ml normal saline (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wang Jiangling
Primary completion
May 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Propofol EC50 for Inducing Loss of Conciousness
2.97; 3.36
PRIMARY
Predicted Effect-site Concentration of Propofol (Ceprop) at Certain Time Points
2.63; 1.97
SECONDARY
Anesthetics Consumption
0.11; 0.13
SECONDARY
Postoperative Exhaust Time
78.0; 85.0

Summary

The beneficial of perioperative usage of thoracic epidural anesthesia and analgesia in various thoracic and upper abdominal surgery are well studied. However, intraoperative data are lacking whether combined thoracic epidural and general anesthesia have effect on the median (50%) effective effect-concentration (EC50) of propofol for inducing loss of consciousness (LOC). We performed this study among patients undergoing open gastrectomy in gastric cancer patients. Sixty patients undergoing open gastrectomy were randomly assigned to two groups with thoracic combined general anesthesia (TEA+GA) or general anesthesia (GA) alone. Target-controlled infusion (TCI) of propofol was used for anesthesia induction. The initial propofol concentration of target effect-site (Ceprop) was 3.5 ug/ml and was increased stepwise by 0.5ug/ml at each 4 min intervals by an un-down sequential method to reach LOC. The predicted Ceprop at the time of LOC, intravenous anesthetics, vasopressor requirement, emergency time from anesthesia and postoperative numeric rating scale (NRS) were recorded and analyzed between two groups.

Eligibility Criteria

Inclusion Criteria

Gastric cancer patients age between 18-75 yrs;

ASA physical state I and II

Undergoing open gastrectomy

Exclusion Criteria

With contraindications to epidural puncture or catheter placement

Chronic or acute (within 48 h) intake of psychotropic drugs, benzodiazepines, anticonvulsants, or opioids; alcoholism

Hepatic, renal, neurological or other organ dysfunctiony

Younger than 18 years or older than 75 years

Allergic to local anesthetic solutions or opioids

Received neo-adjuvant chemotherapy

Refuse to receive epidural puncture

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05124704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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